—#203340

Product

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K201758
Affected lot / code info: Model BF-P190 UDI-DI: 4953170342110

Why it was recalled

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 10/12/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has purchased one or more of the affected bronchoscopes. Olympus requests you to take the following actions: 1. Inspect your facility for the referenced devices and ensure all personnel are completely knowledgeable and thoroughly aware of the Warnings in affected bronchoscope s Operation Manual for use with High-frequency therapy equipment and that Olympus high-frequency compatible bronchoscopes are compatible only with Combination equipment list in operation manual. You may continue to use the device according to the existing instructions and warnings contained in the Instruction for Use. 2. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email (Olympus4907@sedgwick.com) or Fax (866-808-1177). For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-5128. 3. If you have further distributed this product outside of your facility, forward them this notification and appropriately document your notification process. Olympus requests that you report to Olympus complaints, including any injuries associated with procedures involving energy devices used with Olympus bronchoscopes. Please report complaints to the Olympus Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to contact me directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution

Timeline

Recall initiated: 2023-10-12
Posted by FDA: 2023-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203340. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.